DE102006060969B3 - Respirator e.g. endotracheal tube, for use in e.g. veterinary medicine, has arrangement with distal area provided with balloon, where balloon has distal section provided to intrude in esophagus, and rods reversibly running by one tube - Google Patents

Abstract

The respirator has a tube arrangement (33) inserted through a mouth and a throat of a patient, where the arrangement has lens tubes (1, 2) with distal and proximal openings. A length of the arrangement is used for attaching the distal opening to an inlet area of an air tube. A distal area of the arrangement has a balloon (4) that is expandable by supplying a fluid. The balloon has a distal section (37) that is provided to intrude partially in an esophagus and to lock in an expanded condition, and guiding rods (17) reversibly running by one of the tubes.

Description

The The invention relates to a ventilator with a tube arrangement, which is intended to be inserted through the mouth and throat of a patient, wherein the tube assembly a first and a second tube, each with a proximal and a a distal opening, includes, the tube assembly a length which is suitable, the distal opening of the first tube to the entrance area the trachea and the distal opening of the second tube into the esophagus to bring in while the proximal openings outside of the mouth, with the distal region of the tube assembly a balloon which is expandable by supplying a fluid is and in the expanded state, a seal between the inserted tube assembly and the inner wall of the pharynx, the distal balloon a distal portion provided therefor, at least partially enter the esophagus and to close it in the expanded state and wherein the distal end of the second tube passes through the distal portion of the balloon. Of Furthermore, the invention relates to a ventilator with two separate Balloons.

Became conventional ventilators divided into two categories, namely endotracheal and laryngeal masks. endotracheal be over the oral cavity and inserted into the throat of the trachea, at the distal end the endotracheal tube a balloon is attached, which after expansion the space between the outer wall of the tube and the walls the trachea seals. Their advantage is that they are very reliable and a ventilation of the patient over long periods allow. On the other side, the distal tube end must be between the vocal cords carried out which is a significant risk because the vocal cords are very are sensitive and easily damaged. This can cause infection, scar tissue formation, blockage the trachea or lead to permanent hoarseness of the patient. In addition, the introduction is only under view, d. H. with the aid of a laryngoscope or similar, as well as with administration of a muscle relaxant possible.

On on the other hand, laryngeal masks are known that over the oral cavity and the pharynx to the entrance of the trachea, but without to pass the larynx. At the distal end of the laryngeal mask is a arranged inflatable body, which closes the throat airtight above the trachea. Because the Do not put masks in the trachea self-introduced there is no danger for the vocal cords.

The However, laryngeal masks are at risk of developing a leak greater. moreover must the inflatable bodies a laryngeal mask under very high pressure to be expanded to obtain airtight closure.

From the European patent EP 0 971 765 B1 For example, a ventilator with an expandable sealing cuff is known that creates a closure between the tube and the throat. The ventilator has a delimiting strip which projects into the upper area of the esophagus and places the tube in the entrance area of the trachea. Inserting the tube beyond the vocal cords is therefore no longer necessary.

Also in this ventilator However, the problem arises that the trachea against the ingress of liquid from the esophagus (esophagus) only insufficiently protected is. This represents a significant risk as the intrusion of the Strong acidic stomach contents in the lungs can lead to serious pneumonia. The probability of penetration of gastric contents into the pharynx is significant as is common an overpressure builds up in the stomach or the patient also vomits. Furthermore can the ventilator slip during coughing or movement of the patient.

Around to reduce the risk of gastric contents entering the trachea, beats International patent application WO 2005/058402 A1, a ventilator in front the balloon or the sealing sleeve, in the expanded state creates a seal between the tube and the pharynx, with its distal End in the esophagus protrudes to close this in the expanded state. there the sealing collar has a constriction zone to which distal to the tubular distal region of the sealing collar connects. By placing at least a portion of the esophageal seal will be opposite the pharynx closed and the risk of entering stomach contents in the windpipe does not exist anymore. additionally can the ventilator have a second tube, starting from outside of the patient through the sealing cuff into the esophagus is enough to derive in the stomach building up pressure to the outside to be able to or to introduce probes and other instruments.

A different possibility, a closure of the esophagus across from to bring about the throat, is to place a second balloon here, as in WO 96/27404 A1 is shown.

To introduce the balloon / seal WO 2005/058402 A1 proposes a more or less flexible rod (stiletto) within the balloon which extends to the distal end of the balloon and, due to its size and rigidity, advances in comparison with the balloon itself simplified. In addition, the rod has an atraumatic rounding at its distal end to prevent injury to the inner wall of the esophagus.

Problematic Here is that the spherical Design of the distal end of the rod finding the and that Introduce in the entrance area of the esophagus complicated because the entrance to the esophagus at rest very is tight. The finding of the entrance area could indeed be improved, in the flexible rod is provided with a distal tip which correspondingly smaller dimensions has, this would be however, associated with the risk of further insertion into the esophagus the esophageal inner wall to hurt or at least hang on to it. This is before all due to the fact that the esophageal inner wall is not is smooth, but rather a variety of small baggy protuberances and bulges that are called esophageal diverticulum or also Zenker diverticulum can be called. Remains the attending physician while advancing the device with the distal tip in one hanging the said Zenker diverticulum is another advancement not possible anymore. additionally there is a risk that when using too much force the diverticula are torn open by the tip of the device. These Danger would exist especially in emergency situations, since in this case the ventilator very quickly introduced must become.

All in all Thus one stands before the conflict of objectives that to find the entrance area of the esophagus one possible Spitzer wand desirable would be what but with the risk of getting stuck on esophageal diverticula connected is. Although this danger is largely eliminated by the distal end of the rod spherical and is formed relatively thick, which in turn, however, the insertion into the entrance area of the esophagus difficult.

Also in terms of flexibility are the previously arranged in the distal balloon area bars not optimal. On the one hand, one is possible high flexibility desirable, thus the area introduced into the esophagus of the ventilator preferably Atraumatic, on the other hand, a high flexibility makes insertion difficult the esophagus. Conversely, with a relatively stiff rod, insertion into the esophagus relatively easy, the danger of tearing up or the injury of Zenker diverticula, however, is even higher.

Similar Have to compromise be discussed with regard to the design of the tip of the Stabes, because on the one hand a rounded, spherical tip the risk of Wall ruptures decreased, insertion into the esophagus but again difficult.

outgoing from the above disadvantages of the prior art Therefore, the task of a respirator of the aforementioned type for disposal to provide, with the help of which the distal sections of the balloon well in the esophagus introduce without risking injury to the esophageal diverticulum.

The The object is achieved by a respirator with a tube arrangement, which is intended to pass through the mouth and throat of a patient introduced to become, with the tube arrangement a first and a second tube, each with a proximal and a distal opening, includes, the tube assembly a Has length, which is appropriate to the distal opening of the first tube to the entrance area of the trachea and the distal opening of the second tube into the esophagus to bring in while the proximal openings outside of the mouth, with the distal region of the tube assembly a balloon which is expandable by supplying a fluid is and in the expanded state, a seal between the inserted tube assembly and the inner wall of the pharynx, the distal balloon a distal portion provided therefor, at least partially in the esophagus penetrate and close this in the expanded state and the distal end of the second tube passing through the distal section the balloon runs, wherein by the second tube a reversible on and executable Corporate Office runs.

According to the invention, no rod which is firmly integrated into the distal section of the balloon is used, but rather a guide rod which can be easily inserted and removed through the second tube projecting into the esophagus. The guide rod itself is carried out relatively stiff, while the surrounding areas of the balloon are very soft and thus atraumatic. In order to introduce the distal portion of the balloon into the esophagus, the guide rod itself can be carefully advanced, which due to its stiffness is relatively easy to insert into the esophagus. The guide stick protrudes a piece out of the distal end of the balloon. Once the guide rod and surrounding balloon have been inserted into the entrance of the esophagus, the guide rod can be withdrawn slightly (about 10 mm) to continue advancement. That way he stands Guide rod no longer out of the distal end of the balloon, which minimizes the risk of snagging or injury to Zenker diverticula. Possibly. For example, if the treating physician detects that he is encountering resistance with the guide bar, he may further retract the guide bar to continue advancing. In this way, the advantages of a narrow rod at the distal end (easy insertion into the entrance area of the esophagus) and a distal end rounded, rounded rod (minimizing the risk of intrusion into and injury to Zenker's diverticula) are combined. A forward and retractable guide rod allows adaptation to the current treatment situation. In addition, the guide rod at the proximal end can have markings by means of which the doctor can see how far the guide rod has been inserted into the ventilator. In the manner described, a "blind" insertion without use of a laryngoscope is possible.

As soon as the distal portion of the balloon is far enough into the esophagus introduced can be, the senior staff be removed completely. The in the esophagus remaining portions of the balloon are then very soft and atraumatic, causing an injury to the esophageal inner wall hardly to be feared anymore is. The management staff on the other hand, it can be stiffer than the flexible one Bars from the Prior art, as the management staff forward and retractable is and ultimately completely removed. The soft and atraumatic Training in the esophagus remaining portions of the balloon also has the further advantage that forces occurring here because of the flexibility the balloon can be easily absorbed. At from the state of the Technically known devices, however, these forces along the length of the rod are transmitted to the hypopharynx, so too There is a risk of injury. Basically, one is possible size Flexibility, in particular also lateral, desirable, but you have to pay attention be that in the esophagus In this case, the second tube should not collapse, so that access to the esophagus remains open through the second tube. This can be achieved by using a suitable material for reach the second tube.

Of the Balloon can be made of a relatively thin-walled Made of material that casts no wrinkles to a good seal to ensure. A typical material for making the ventilator is for example silicone. However, other plastics are also suitable in principle for example, PVC, polyurethane or SEBS (styrene-ethylene / butylene-styrene). The production of a balloon, in the expanded state, the desired shape has, is with conventional, From the prior art known methods readily possible.

advantageously, the balloon has a necking zone between the proximal and distal ends, in the expanded state, a constriction of the balloon in the area the constriction zone causes. Corresponding are both the proximal end and the distal end of the oblong Balloons thicker than the area of constriction. The larger dimensions at the proximal and distal end each effect a tight seal once in the area of the pharynx, on the other hand in the area of the esophagus. The constriction zone is advantageous in that in the entrance area of the esophagus a sphincter muscle is located, which engage in the area of the constriction and fix the balloon in the longitudinal direction. Furthermore causes the sphincter muscle tissue of the esophagus peristalsis in Direction to the stomach, the good fit of the ventilator and occlusion of the esophagus ensures. In particular, this prevents due to gases in the stomach escaping pressure in the direction of the trachea escapes.

in the In connection with the invention, the terms distal and proximal used as follows: Proximal denotes the direction to the outside of the body, d. H. to the attending physician, distally the direction to the inside of the body into it. The distal end of the balloon / gasket is accordingly for example, the end, which is further inside the body, d. H. in the esophagus located.

Suitably, way indicates the constriction zone a length from 1 to 4 cm, in particular 1.5 to 3 cm, for example 2 cm. It should be noted that the integrally formed balloon in the Usually have no sharp transitions so that also the constriction zone has no sharp border. Rather, the balloon reduces to the constriction zone gradually its diameter and enlarges it again in the direction of the distal end, the area with reduced Diameter one length in the above range.

Furthermore, it is advantageous if the distal portion of the balloon in the expanded state is at least partially tubular, ie in the region distal to the constriction zone. This area preferably has a length of 1.5 to 10 cm. In principle, however, the length of 10 cm can also be exceeded, since the length of the esophagus from the pharynx to the entrance of the stomach is significantly longer. However, insertion of the ventilator through the patient's mouth becomes more difficult with a longer tubular portion. However, to achieve a good seal, it is preferable if the length of the tubular section is longer than about 2 cm, and preferably longer than about 3.5 cm. On the other hand, however, the area should preferably not be longer than 8, preferably not longer than 6 cm.

there It should be noted that the exact dimensions of the ventilator depending on Patients are. For example, appropriate ventilators are used to treat Children usually have smaller proportions than those for treatment of adults. About that In addition, the use of the ventilators according to the invention in veterinary medicine Conceivable area, where in turn other dimensions are required.

According to one alternative embodiment of the Invention has the ventilator not a balloon that extends from the pharynx into the esophagus extends into it, but two balloons that expand independently of each other are or over have a connection, the for Balancing the pressure between the balloons. According to this alternative embodiment Accordingly, the invention relates to a respirator with a Tubing, which is intended to be inserted through the mouth and throat of a patient, wherein the tube assembly a first and a second tube, each with a proximal and a a distal opening, includes, the tube assembly a length which is suitable, the distal opening of the first tube to the entrance area the trachea and the distal opening of the second tube into the esophagus to bring in while the proximal openings outside of the mouth, with the distal region of the tube assembly having a first and a second balloon by supplying a fluid expandable, wherein the first balloon in the expanded state a seal between the inserted tube assembly and the inner wall of the Rachens brought about and the second balloon provided for it is, at least partially, in the esophagus penetrate and close this in the expanded state and wherein the distal end of the second tube through the second balloon runs, where through the second tube a reversible on and executable Corporate Office runs.

Also Here, the second balloon in the expanded state in the distal Be region at least partially tubular, wherein in terms of dimensions for the first embodiment said applies.

The second tube, which extends through the distal portion of the balloon or the second balloon, according to the invention not only has the task of harboring the guide rod, but also has the advantage that caused by gases in the stomach or regurgitation overpressure from the stomach and the esophagus can escape. Even in the case of vomiting, the stomach contents can escape through the second tube. Since the pressure in the area of the stomach is kept low, a lower pressure will be sufficient to hold the balloon in place. For example, while conventional laryngeal masks often require pressures in the range of 60 cm H ₂ O, pressures in the range of 15 to 20 cm H ₂ O are generally sufficient here. The application of lower pressures is particularly advantageous in the case of long treatment times, so that the ventilator according to the invention can also be used in the elective area, ie in the area of permanent treatments, while laryngeal masks are often used only in emergency medicine because use over periods of more than 30 to 45 min is difficult. In contrast, with the ventilator according to the invention also a lengthy operation of three, four or more hours can be performed.

One Another advantage of the second tube is that instruments be introduced thereby can, For example, probes or cameras for the inspection of the esophagus or the stomach. Even foods or medicines can pass through the second tube are introduced.

As already mentioned at the beginning, should be the senior staff even from a relatively stiff Material exist to insert in the esophagus as simple as possible close. As the senior staff is easily inserted and withdrawn and after the introduction of tubing completely removed is an injury to the esophageal inner wall nevertheless not to be feared.

Furthermore It is beneficial if the management staff is already preformed, so that the senior staff the way from the oral cavity to the esophagus Searches virtually automatically, without the attending physician making major corrections must perform. For this should be the senior staff have a curvature, the course of the connection of oral cavity, pharynx and esophagus equivalent. In particular, the guide rod should be shaped so that an accidental insertion excluded into the trachea is.

Optionally, the guide rod can also be made of a deformable material, so that the treating physician can make corrections in the form of the guide rod, if necessary, in order to adapt it to the respective patient. This could be of importance, for example, when using the guide rod when inserting into the oso phagus remains or the patient has an unusual form of the oral cavity or pharynx.

meaningful is it about it out, the senior staff with a soft distal tip. Also useful is to make the distal tip rounded. Both causes that the distal tip of the guide rod preferably Atraumatic is what increases the risk of injury to the esophageal inner wall and in particular the diverticulum present here further reduces.

The Interior of the two tubes of the tube arrangement should be complete be separated from each other. In this way, a thorough mixing of gases or liquids, which are introduced or discharged through the tubes prevented.

to further improvement of the seat of the ventilator can the area of the balloon or the balloon that is in the expanded state a seal between the tube assembly and the inner wall of the pharynx, a wedge-shaped structure with a proximally larger volume as distal. In this way, the respirator or the therefor provided distal areas of the ventilator further in the direction of the esophagus pushed.

The ventilator according to the invention can used in various fields of medicine, both in human as well as in veterinary medicine. The ventilator is both in the field of emergency medicine as well as in the area of intensive care, of anesthesia, can be used for operations etc. In the emergency medicine you will be there the senior staff i. d. R. form somewhat stiffer, since the rapid introduction of the ventilator stands in the foreground.

The Invention will be with reference to the accompanying figures explained in more detail. It demonstrate

1 a side view of a first embodiment of the ventilator according to the invention;

2 the ventilator off 1 , introduced into a patient;

3 a cross section along the line III-III 1 and

4 a cross section along the line IV-IV 1 ,

In 1 the ventilator according to the invention is shown in side view. The ventilator has a tube arrangement 33 with a first tube (the breathing tube) 1 and a second tube (the esophageal tube) 2 on. The distal opening 14 of the breathing tube 1 is intended to be placed at the entrance of the trachea.

Furthermore, the ventilator has a balloon 4 arising from a proximal section 34 and a distal section 37 composed of a constriction zone 16 connected to each other. The balloon 4 is by supplying a fluid across the channel 8th expandable. In the expanded state, the proximal section leads 34 of the balloon 4 a seal between the inserted tube assembly 33 and the inner wall of the pharynx, while the distal portion 37 of the balloon 4 extending into the esophagus. The distal section 37 is substantially tubular and typically has a length C in the range of 1.5 to 10 cm, while the necking zone 16 typically has a length B of 1 to 4 cm.

First tube 1 and second tube 2 are in a common shell 3 accommodated. For proper placement, the ventilator has a strip 9 which can easily extend into the esophagus and prevents the first tube 1 inserted too far into the trachea or the balloon 4 the trachea closes. The air supply and breathing is according to the arrow 41 still possible. The second tube 2 with its distal opening 5 causes excess pressure in the stomach to escape easily.

Through the second tube 2 runs a management staff 17 which is relatively stiff and through the esophageal tube 2 can be pushed in and out. The management staff 17 has a distal tip 18 on, which is rounded and therefore atraumatic formed. To insert the ventilator, the guide rod 17 Due to its stiffness it is relatively easy to enter the esophagus 6 can be inserted, advanced, the other areas of the ventilator, in particular the distal section 37 of the balloon 4 will be postponed accordingly. Once the entrance area of the esophagus 6 is overcome, the senior staff 17 be withdrawn a little so that he is not over the distal section anymore 37 of the balloon 4 also available. Subsequently, the advancement into the esophagus 6 continued, due to the withdrawn senior staff 17 the risk of injury to the esophageal inner wall is minimized, on the other hand, however, the balloon 4 with his still existing management staff 17 has sufficient rigidity to allow advancement. Once the ventilator including the balloon 4 has reached his final position becomes the senior staff 17 pulled out proximally from the ventilator and away. This leaves only the soft atraumatic balloon 4 even in the esophagus 6 ,

In 2 is the ventilator off 1 in the throat 7 and the esophagus 6 presented to the patient introduced. One recognizes how the distal area of the balloon 4 in the esophagus 6 protrudes and this closes after expansion, with the second tube 2 with its distal opening 5 deriving an overpressure from the stomach is still possible. The management staff 17 is already removed in this presentation. The constriction zone 16 of the balloon 4 is adjacent to the sphincter muscle tissue 15 ,

The first tube 1 is positioned so that the distal opening 14 of the breathing tube 1 at the entrance of the trachea 12 is positioned, but does not have to be pushed into this. That's how the vocal cords are made 13 protected from injury.

In 3 is a cross section through the tube assembly 33 shown along the line III-III. In the common shell 3 are the breathing tube 1 , the second tube 2 as well as a canal 8th arranged, through which a fluid, usually air, into the balloon 4 is introduced.

In 4 is a cross-section through the proximal section 34 of the balloon 4 shown along the line IV-IV. The proximal section 34 has a U-shaped cross section with two lateral arms 36 so that there is a gap in which the distal end 14 of the breathing tube 1 and the strip 9 are arranged. This space is bounded to the right by a wall A of the balloon.

Claims (15)

Ventilator with a tube arrangement ( 33 ), which is provided through the mouth and throat ( 7 ) of a patient, the tube arrangement ( 33 ) a first and a second tube ( 1 . 2 ) with a proximal and a distal opening, the tube arrangement ( 33 ) has a length which is suitable for the distal opening ( 14 ) of the first tube ( 1 ) to the entrance area of the trachea ( 12 ) and the distal opening of the second tube ( 2 ) in the esophagus ( 6 ) while the proximal openings remain outside of the mouth, with the distal portion of the tube assembly ( 33 ) a balloon ( 4 ), which is expandable by supplying a fluid and in the expanded state, a seal between the inserted tube assembly ( 33 ) and the inner wall of the pharynx ( 7 ), wherein the distal balloon ( 4 ) a distal portion ( 37 ), which is intended at least partially into the esophagus ( 6 ) and to close it in the expanded state and wherein the distal end of the second tube ( 2 ) through the distal portion ( 37 ) of the balloon ( 4 ), characterized by a through the second tube ( 2 ) extending reversibly and executable guide rod ( 17 ). Ventilator according to claim 1, characterized in that the balloon ( 4 ) a constriction zone ( 16 ) between the proximal and distal ends of the balloon, which in the expanded state, a constriction of the balloon ( 4 ) in the area of the constriction zone ( 16 ) brought about. A ventilator according to claim 2, characterized in that the constriction zone ( 16 ) has a length of 1 to 4 cm, in particular 1.5 to 3 cm, for example 2 cm. Breathing apparatus according to one of claims 1 to 3, characterized in that the distal portion ( 37 ) of the balloon ( 4 ) is at least partially tubular in the expanded state. Breathing apparatus according to claim 4, characterized in that the tubular portion ( 37 ) of the balloon ( 4 ) has a length between 1.5 and 10 cm. Breathing apparatus according to claim 4 or 5, characterized in that the tubular portion ( 37 ) of the balloon ( 4 ) is longer than 2 cm and preferably longer than 3.5 cm. Breathing apparatus according to one of claims 4 to 6, characterized in that the tubular portion ( 37 ) of the balloon ( 4 ) is shorter than 8 cm and preferably shorter than 6 cm. Ventilator with a tube arrangement ( 33 ), which is provided through the mouth and throat ( 7 ) of a patient, the tube arrangement ( 33 ) a first and a second tube ( 1 . 2 ), each with a proximal and a distal opening, comprises the tube arrangement ( 33 ) has a length which is suitable for the distal opening ( 14 ) of the first tube ( 1 ) to the entrance area of the trachea ( 12 ) and the distal opening ( 5 ) of the second tube ( 2 ) in the esophagus ( 6 ) while the proximal openings remain outside of the mouth, with the distal portion of the tube assembly ( 33 ) comprises a first and a second balloon which are expandable by the supply of a fluid, wherein the first balloon in the expanded state, a seal between the inserted tube assembly ( 33 ) and the inner wall of the pharynx ( 7 ) and the second balloon is intended, at least partially, to enter the esophagus ( 6 ) penetrate and the in the expanded state and with the distal end of the second tube ( 2 ) passes through the second balloon, characterized by a through the second tube ( 2 ) reversibly insertable and executable guide rod ( 17 ). Breathing apparatus according to one of claims 1 to 8, characterized in that the guide rod ( 17 ) consists of a stiff material. Ventilator according to one of claims 1 to 9, characterized in that the guide rod ( 17 ) the path from the mouth to the esophagus ( 6 ) is preformed accordingly. Ventilator according to one of claims 1 to 10, characterized in that the guide rod ( 17 ) is made of a deformable material. Breathing apparatus according to one of claims 1 to 11, characterized in that the guide rod ( 17 ) has a soft distal tip. Breathing apparatus according to one of claims 1 to 12, characterized in that the guide rod ( 17 ) has a rounded distal tip. Ventilator according to one of claims 1 to 13, characterized in that the interior of the two tubes ( 1 . 2 ) of the tube arrangement ( 33 ) is separated from each other. Ventilator according to one of claims 1 to 14, characterized in that the area of the balloon ( 4 ) or the balloon, in the expanded state, a seal between the tube arrangement ( 33 ) and the inner wall of the pharynx ( 7 ) has a wedge-shaped structure with a proximally larger volume than distally, allowing the ventilator to move towards the esophagus (Fig. 6 ) is pushed.